Continuous Ambulatory Haemofiltration Device

ABSTRACT

A Continuous Ambulatory Haemofiltration consisting of an outer casing, multifunction pump, haemofilter, reversed osmosis filter, power source, drainage bag, blood lines and fluid lines, characterized in that the haemofiltrate from the haemolfilter is moved to a reversed osmosis filter. The ultrafiltrate fluid from the reversed osmosis filter flows to the out-flow tube of the haemofilter veineus line through a specific fluid line. The exit of the reversed osmosis filter is connected to a drainage bag. The multifunction pump moves blood from the jagular perm catherter to the haemofilter, and fluids between the haemofilter, reversed osmosis filter, veineus line and drainage bag. An electrode is placed at the in-flow tube of the haemofilter to measure incoming blood osmolality. The electrode is connected to a microprocessor that is further connected to a computer-controlled valve at the out-flow line of the reversed osmosis filter. The microprocessor is connected with a memory card.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of the priority filing date inPCT/CN2007/002663 referenced in WIPO Publication WO 2008/104108. Theearliest priority date claimed is Feb. 28, 2007.

FEDERALLY SPONSORED RESEARCH

Not Applicable

SEQUENCE LISTING OR PROGRAM

Not Applicable

STATEMENT REGARDING COPYRIGHTED MATERIAL

Portions of the disclosure of this patent document contain material thatis subject to copyright protection. The copyright owner has no objectionto the facsimile reproduction by anyone of the patent document or thepatent disclosure as it appears in the Patent and Trademark Office fileor records, but otherwise reserves all copyright rights whatsoever.

BACKGROUND

1. Technical Field

This invention relates to a medical apparatus, particularly a ContinuousAmbulatory Haemofiltration Device.

2. Technical Background

The kidney has many vital functions which include removal of excessivewater and electrolytes and removal of metabolic waste product. When thekidney fails to do its functions, a patient will die unless he receivesrenal replacement therapy. The available renal replacement therapy thesedays are the following:

Renal transplantation. A shortage of graft kidneys makes this optionlimited. In addition, patients must be placed on expensiveimmunosuppressive medications that have a lot of side effects, andpatients must be regularly monitored. There are many contraindication ofrenal transplantation.

Peritoneal dialysis. This requires large amounts of expensive fluids andother disposables. In addition, it has many complications, and theefficiency of the peritoneal membrane decreases markedly with time. Thistype of renal replacement therapy requires daily effort from the patientfor fluid exchange.

Conventional haemodialysis. Large numbers of end stage renal failurepatients receive conventional haemodialysis which requires large numberof nursing staff, a lot of expensive fluids and disposables. Inaddition, patients must come to the haemodialysis unit about 3 times perweek and be injected with two large needles in each haemodialysissession. Furthermore, this type of therapy has a lot of complications.In haemodialysis units, conventional haemofiltration andhaemodiafiltration can be performed but require even more expensivefluids and disposables.

DESCRIPTION OF THE INVENTION

The present invention decreases the medic care cost, inconvenience andagony of renal failure patients. The object of the present invention isto provide a small-sized, ambulatory haemofiltration device that canproduce hameofiltration replacement solution itself.

The technical scheme to achieve the invention is as follows: AContinuous Ambulatory Haemofiltration (CAHF) Device, consisting of anouter casing, a multifunction pump, a haemofilter, a reversed osmosisfilter, a power source, a drainage bag, blood lines and fluid lines,characterized in that blood moves from a patient to a haemofilter, thenthe haemofiltrate produced therein is moved to a reversed osmosisfilter.

The ultrafiltrate fluid from the reversed osmosis filter flows to theout-flow tube of the haemofilter veineus line through a specific fluidline. The exit of the reversed osmosis filter is connected to a drainagebag. The role of the a multifunction pump is to move the blood from thejagular perm catherter to the haemofilter, and to move fluids betweenthe haemofilter, the reversed osmosis filter, the veineus line and thedrainage bag. An electrode is placed at the in-flow tube of thehaemofilter to measure the incoming blood osmolality. The electrode isconnected to a microprocessor that is further connected to acomputer-controlled valve that is placed at the out-flow line of thereversed osmosis filter. The microprocessor is connected with a memorycard.

The in-flow line to the reversed osmosis filter, the out-flow line ofthe reversed osmosis filter, and the ultrafiltrate line from thereversed osmosis filter, are connected to a volumetric device to measurethe volumes of fluids going through those lines. The volumetric deviceis connected with the microprocessor that is connected to the memorycard.

The power source is in the form of two rechargable batteries that areconnected in parallel form. The multifunctional pump is a coaxial(axle-sharing) multifunctional pump. There are two impellers driven byone micro electric motor. The one impeller impels the blood from thepatient's body to the haemofilter, and the haemofiltrate from thehaemofilter to the reversed osmosis filter. The other impeller impelsthe ultrafiltrate (product fluid) from the reversed osmosis filter tothe tube connected with the patient's body vein.

The haemofilter and the reversed osmosis filter are placed in tunnels ateither side of the casing, and other parts are placed in the centerbetween the two tunnels. There are 2 power indicating alarms on theouter casing of the device. One indicates low blood flow through thehaemofilter and the other one indicates low battery power. There is abinding belt on the outer casing. A valve is placed at the fluid linethat connects the reversed osmosis filter and the inlet of haemofilter.A valve is placed at the fluid line that connects the reversed osmosisfilter and haemofilter itself. The branch of the fluid line carrying thedialysate to the hameofilter itself must enter to the haemofilterthrough the upper end of one side of the haemofilter to the dialysatecompartment.

A store of mixed powder of sodium chloride and sodium biacarbonate isprovided to add enough sodium chloride or biacarbonate to theultrafiltrate from the reversed osmosis filter. Part of the ultrfiltratefrom the reverse osmosis filter will go through cartilage houses,through small branch tube lines with a one-way valve, toward thecartilage houses.

There are electrodes to measure the sodium concentration in the fluidcoming from each cartilage house before it reenters the main line goingto the haemofilter. There are controll valves on the exit of each microcartilage house. The sodium concentrations measurments will betransmitted to the electronic microprocesor which will send informationto the memory card and to the pre-programmed electronic card, which willthen adjust the amount of fluid coming from the cartilges houses throughthe controll valves.

There are replacement microcartilages. One contains sodium bicarbonatepowder and the another contains powder of the other requiredelectrolytes, including, calcium, potassium, and sodium chloride. Eachone of these microcartilages will be fixed to one of the cartilagehouses.

The present device, having a simple and portable structure, can beeasily bound to a patient's body. When the power-indicating alarm isactivated, one of the batteries can be replaced without affecting thecontinuous operation of the device as the two batteries are connected inparallel form. If the blood flow alarm light turns on, it indicates afailure of the device function and the patient must go to the hospitalimmediately. The haemofiltrate from the haemofilter is then moved to areversed osmosis filter. The ultrafiltrate from the reversed osmosisfilter flows back to a patient's body as replacement solution. Thisgreatly reduces the medical care cost of a patient.

SUMMARY OF THE INVENTION

The present invention decreases the medic care cost, inconvenience andagony of renal failure patients. The object of the present invention isto provide a small-sized, ambulatory haemofiltration device that canproduce hameofiltration replacement solution itself.

The invention is a Continuous Ambulatory Haemofiltration (CAHF) Deviceconsisting of an outer casing, a multifunction pump, a haemofilter, areversed osmosis filter, a power source, a drainage bag, blood lines andfluid lines, characterized in that the haemofiltrate from thehaemolfilter is moved to a reversed osmosis filter; ultrafiltrate fluidfrom the reversed osmosis filter flows to the out-flow tube of thehaemofilter veineus line through a specific fluid line; the exit of thereversed osmosis filter is connected to a drainage bag; themultifunction pump moves blood from the jagular perm catherter to thehaemofilter, and moves fluids between the haemofilter, reversed osmosisfilter, veineus line and drainage bag; an electrode placed at thein-flow tube of the haemofilter measures the incoming blood osmolality,the electrode is connected to a microprocessor that is further connectedto a computer-controlled valve placed at the out-flow line of thereversed osmosis filter; and the microprocessor is connected to a memorycard.

The present device, having a simple and portable structure, can beeasily bound to a patient's body. When the power-indicating alarm isactivated, one of the batteries can be replaced without affecting thecontinuous operation of the device as the two batteries are connected inparallel form. If the blood flow alarm light turns on, it indicates afailure of the device function and the patient must go to the hospitalimmediately. The haemofiltrate from the haemofilter is then moved to areversed osmosis filter. The ultrafiltrate from the reversed osmosisfilter flows back to a patient's body as replacement solution. Thisgreatly reduces the medical care cost of a patient.

FIGURES

FIG. 1 is a structural view of the inside of the device;

FIG. 2 is an illustrative view of the back of the device;

FIG. 3 is an illustrative view of the connection of major parts of thedevice;

FIG. 4 is an illustrative view of the cartilage houses;

FIG. 5 is an illustrative view of the connecting scheme between thedevice and artery and veins

DESCRIPTION

As shown in FIGS. 1 and 2, the Continuous Ambulatory Haemofiltration(CAHF) Device consists of an outer casing(1), a multifunction pump(2), ahaemofilter(3), a power source(4), a drainage bag(5), blood lines andfluid lines. The haemofiltrate from the haemolfilter(3) is moved to areversed osmosis filter(8) through a fluid line(7). The exit of thereversed osmosis filter(8) is connected to a drainage bag(5). Theultrafiltrate from the reversed osmosis filter(8) is connected to theinlet, the exit of haemofilter(3), and to the haemofilter(3) itself viaa fluid line(12), respectively. Valves (16 and 17) are placed at thefluid lines that connect the reversed osmosis filter(8) and the inlet ofthe haemofilter(3), and the haemofilter(3) itself, respectively. Thebranch of the fluid line carrying the dialysate to the hameofilter (3)itself must enter to the haemofilter(3) through the upper end of oneside of the haemofilter(3) to the dialysate compartment. Themultifunction pump (2) moves the blood from the jagular permcatherter(18) to the haemofilter(3), and moves fluids between thehaemofilter(3), the reversed osmosis filter(8), the fluid line(12), andthe drainage bag(5).

The multifunction pump(2) has two impellers driven by one micro electricmotor. One impeller impels the blood from the patient's body to thehaemofilter(3), and the haemofiltrate from the haemofilter(3) to thereversed osmosis filter(8). The other impeller impels the ultrafiltrate(product fluid) from the reversed osmosis filter(8) to the tubeconnected with the fluid line(12). An electrode(19) is placed at thein-flow tube of the haemofilter(3) to measure the incoming bloodosmolality. The electrode(19) is connected to a microprocessor(20) thatis further connected to a computer-controlled valve(21) that is placedat the out-flow line of the reversed osmosis filter(8). Themicroprocessor is connected with a memory card(23). Electrodes (24, 25and 26) are placed at the inlet, exit and out-flow line of theultrafiltrate of the reversed osmosis filter(8), respectively. The threeelectrodes are connected to volumetric devices to measure fluids goingthrough those lines. The volumetric devices are connected with amicroprocessor(27) to send those information to a memory card(23). Thepower source(4) is composed of two rechargeable batteries connected inparallel form. The haemofilter(3) and the reversed osmosis filter(8) areplaced in tunnels at either side of the casing, and other parts areplaced in the center between the two tunnels.

Two light alarms(28) are placed on the outer casing(1). One indicateslow blood flow through the haemofilter, and the other one indicates lowbattery power. A binding belt(29) is mounted on the outer casing(1). Astore of mixed powder of sodium chloride and sodium biacarbonate (30) isprovided to add enough sodium chloride or biacarbonate to theultrafiltrate from the reversed osmosis filter(8).

In order to make this invention better understood, the working processof the device is concisely described hereunder. Blood flows from thejagular perm catherter to the haemofilter. The purified blood flows backto the patient's body. The haemofiltrate is moved to the reversedosmosis filter. The rejected fluid by the reversed osmosis filter flowsto the drainage bag, while the ultrafiltrate flows back to the patient'sbody as replacement solution. To avoid clotting in the haemofilter, partof the ultrafiltrate (20-30%) from the reversed osmosis filter must beconnected to incoming blood through the haemofilter. Part of theultrafiltrate can also be connected to the haemofilter itself asdialysate. The percentage of ultrafiltrate to the inlet of thehaemofilter, or to the haemofilter itself, can be adjusted by a doctorby adjusting the valves on the lines going to these sites. An electrodeis placed at the in-flow tube of the haemofilter to measure the incomingblood osmolality. The electrode feedbacks the measurement to amicroprocessor that controls the operation of a valve being placed atthe out-flow line of the reversed osmosis filter, and thereby controlsthe volume of fluid flowing into the patient's body according to thepatient's blood osmolality. All relevant information is stored in thememory card. Electrodes (24, 25 and 26) are placed at the inlet, exitand out-flow line of the ultrafiltrate of the reversed osmosis filter,respectively. The three electrodes are connected with a volumetricdevice and with a microprocessor(27) that stores information in memorycard(23) regarding the amount of fluids going in and out of the reversedosmosis filter. In this way, a patient need not see a doctor frequently,and he/she only needs to see a doctor once a month to have his/herstatus monitored by a doctor who checks the information in the memorycard using a computer. If needed, part of the ultrafiltrate from thereverse osmosis filter can go through cartilage houses[no. 35 and no.38], as seen in FIG. 4, through small branch tube lines with a one-wayvalve pointing toward the cartilage houses.

There are electrodes to measure the sodium concentration in the fluidcoming from each cartilage house before it reenters the main line goingto the haemofilter [No. 40 in FIG. 4]. There are control valves on theexit of each micro cartilage house [no. 39 in FIG. 4]. The sodiumconcentration measurements goes to an electronic microprocessor whichwill send information to the memory card and to the programmedelectronic card. Then the electronic microprocessor will adjust theamount of fluid coming from the cartilges houses through the controlvalves no. 39. There are replacement microcartilages [no. 36 in FIG. 4].One contains sodium bicarbonate powder and the another contains powderof the other required electrolytes, including, calcium, potassium, andsodium chloride. Each of these microcartilages are fixed to one of thecartilage houses. The device is fixed to the right side of the chest ofthe patient, or other adequate place, by a binding belt where it can beconnected to the right-sided jagular perm catheter. In addition, thedevice can be connected to an artery[no. 33 in FIG. 5] and vein [no. 34in FIG. 5]. In the event the device is pulled out accidently, bothartery and vein will be closed by pulled flaps. The flaps will be pulledaway from the opening of the by pass tube [no. 32 in FIG. 5] because,during accedental pulling of the device, the connecting piece of thedevice will pull the flaps closed. This mechanism is designed to avoidbleeding in the event of an accidental pulling of the device.

1. A Continuous Ambulatory Haemofiltration (CAHF) Device consisting ofan outer casing, a multifunction pump, a haemofilter, a reversed osmosisfilter, a power source, a drainage bag, blood lines and fluid lines,characterized in that: the haemofiltrate from the haemolfilter is movedto a reversed osmosis filter; ultrafiltrate fluid from the reversedosmosis filter flows to the out-flow tube of the haemofilter veineusline through a specific fluid line; the exit of the reversed osmosisfilter is connected to a drainage bag; the multifunction pump movesblood from the jagular perm catherter to the haemofilter, and movesfluids between the haemofilter, reversed osmosis filter, veineus lineand drainage bag; an electrode placed at the in-flow tube of thehaemofilter measures the incoming blood osmolality, the electrode beingconnected to a microprocessor that is further connected to acomputer-controlled valve placed at the out-flow line of the reversedosmosis filter, and the microprocessor being connected to a memory card.2. The Continuous Ambulatory Haemofiltration Device according to claim1, characterized in that the in-flow line to the reversed osmosisfilter, the out-flow line from the reversed osmosis filter, and theultrafiltrate line from the reversed osmosis filter are connected to avolumetric device to measure the volumes of fluids going through thoselines, the volumetric device being connected to the microprocessor thatis connected to the memory card.
 3. The Continuous AmbulatoryHaemofiltration Device according to claim 1, characterized in that thepower source is in the form of two rechargable batteries that areconnected in parallel form.
 4. The Continuous Ambulatory HaemofiltrationDevice according to claim 2, characterized in that the power source isin the form of two rechargable batteries that are connected in parallelform.
 5. The Continuous Ambulatory Haemofiltration Device according toclaim 1, characterized in that the multifunctional pump is coaxial(axle-sharing) with at least two impellers driven by at least one microelectric motor, one impeller impels the blood from the patient's body tothe haemofilter, and impels the haemofiltrate from the haemofilter tothe reversed osmosis filter, and the other impeller impels theultrafiltrate (product fluid) from the reversed osmosis filter to thetube connected with the patient's body vein.
 6. The ContinuousAmbulatory Haemofiltration Device according to claim 2, characterized inthat the multifunctional pump is coaxial (axle-sharing) with at leasttwo impellers driven by at least one micro electric motor, one impellerimpels the blood from the patient's body to the haemofilter, and impelsthe haemofiltrate from the haemofilter to the reversed osmosis filter,and the other impeller impels the ultrafiltrate (product fluid) from thereversed osmosis filter to the tube connected with the patient's bodyvein.
 7. The Continuous Ambulatory Haemofiltration Device according toclaim 1, characterized in that the haemofilter and the reversed osmosisfilter are placed in tunnels at either side of the outer casing, andother parts are placed in the center between the two tunnels.
 8. TheContinuous Ambulatory Haemofiltration Device according to claim 1,characterized in that the device is fixed to the right side of the chestof the patient by a binding belt where it is connected to theright-sided jagular perm catheter, the device being connected with anartery and vein, and if pulled out accidentally, connecting pieces ofthe device cause both artery and vein to close by pulling flaps awayfrom the opening of a by pass tube so that the blood will go directlyfrom the artery to the vein through the by pass tube to avoid bleeding.9. The Continuous Ambulatory Haemofiltration Device according to claim1, characterized in that part of the ultrafiltrate (20-30%) from thereversed osmosis filter can be connected to incoming blood through thehaemofilter to dilute the blood and avoid clotting in the haemofilter.10. The Continuous Ambulatory Haemofiltration Device according to claim1, characterized in that the ultrafiltrate fluid from the reversedosmosis filter can be used as a dialysate to perform haemodialysis orhaemodiafiltration, given that the fluid line carrying the dialysate tothe hameofilter enters the haemofilter through the upper end of one sideof the haemofilter to the dialysate compartment.
 11. The ContinuousAmbulatory Haemofiltration Device according to claim 1, characterized inthat a store of mixed powder of sodium chloride and sodium biacarbonatecan be provided to add sodium chloride or biacarbonate to theultrafiltrate from the reversed osmosis filter if needed.
 12. AContinuous Ambulatory Haemofiltration (CAHF) Device consisting of anouter casing, a multifunction pump, a haemofilter, a reversed osmosisfilter, a power source, a drainage bag, blood lines and fluid lines, atleast two replaceable microcartilage, and at least one cartilage house,characterized in that: the haemofiltrate from the haemolfilter is movedto a reversed osmosis filter; ultrafiltrate fluid from the reversedosmosis filter flows to the out-flow tube of the haemofilter veineusline through a specific fluid line; the exit of the reversed osmosisfilter is connected to a drainage bag; the multifunction pump movesblood from the jagular perm catherter to the haemofilter, and movesfluids between the haemofilter, reversed osmosis filter, veineus lineand drainage bag; an electrode placed at the in-flow tube of thehaemofilter measures the incoming blood osmolality, the electrode beingconnected to a microprocessor that is further connected to acomputer-controlled valve placed at the out-flow line of the reversedosmosis filter, the microprocessor being connected to a memory card; andthe at least two replaceable microcartilages, one containing sodiumbicarbonate powder and the other containing other needed electrolytepowder including calcium, potassium and sodium chloride, are fixed on acorresponding cartilage house where part of the ultrafiltrate from thereversed osmosis filter can pass through and mix with those electrolytesbefore mixing again with the main stream of ultrafiltrate going back tothe blood and returning to the body.
 13. The Continuous AmbulatoryHaemofiltration Device according to claim 12, wherein the electrodesconnected to the microprocessor measuring sodium concentrations arefixed on small tube branches returning the ultafiltrate after it mixeswith the electrolytes going back to the main stream ultrafiltratereturning to the blood;
 14. The Continuous Ambulatory HaemofiltrationDevice according to claim 12, wherein the microprocessor controls valvesfixed on the exits of the cartilage houses so that the rightconcentrations of the electrolytes in the ultrafiltrate going back tothe blood is assured.
 15. The Continuous Ambulatory HaemofiltrationDevice according to claim 1, wherein the outer casing of the devicecomprises at least two light alarms, one indicating low blood flow inthe device and the other indicating low battery power.